Smart Technology Facilitated Venous Thromboembolism Prophylaxis Based on Bundled Evidence-based Prevention Strategies

Venous Thromboembolism Clinical Trial

— SmaVTE-BEST  

Official title:

Smart Technology Facilitated In-hospital Venous Thromboembolism Prophylaxis Based on Bundled Evidence-based Prevention Strategies: the SmaVTE-BEST Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06353373
• Other study ID #: HZKY-PJ-2024-7
• Status: Not yet recruiting
• Start date: September 1, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Navy General Hospital, Beijing
• Contact: ZHI-GENG JIN, Doctor
• Phone: 8615801402223
• Email: lwgjzg[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Venous thromboembolism (VTE) is the third leading cause of cardiovascular disease deaths globally, and its incidence is increasing over the years. Hospital-acquired VTE accounts for approximately 75% of all deaths attributed to VTE. However, only half of patients with indications for VTE prophylaxis take preventive measures, and high rates of inappropriate VTE prophylaxis prescribing contribute to the gap between VTE prophylaxis and guidelines. To further minimize the gap between clinical practice and guidelines, a range of strategies have been employed across various fields of VTE prophylaxis. One of the most effective measures is the utilization of a Clinical Decision Support System (CDSS). Smart technology-based CDSS facilitates automated evaluation of VTE risk and detection, addressing issues at both the beginning and end of the in-hospital VTE prevention process. but there is still a lack of research on how to effectively implement evidence-based VTE prophylaxis in the middle of the process.

In our hospital, routine use of DeVTEcare system (a CDSS for VTE risk assessment and integrated care) for in-hospital management of VTE has been launched since 2021. This study aims to investigate the effect of integrating bundled guideline-based VTE prevention strategies into the DeVTEcare system on in-hospital VTE prophylaxis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15626
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Discharged patients who were =18 years of age at admission were included in the observation cohort. If a patient had multiple hospitalizations, information on only the longest hospitalization was included in the study.

Exclusion Criteria:

• Lack of diagnostic information;

• Length of hospitalization = 24 hours;

• Patients on anticoagulation therapy at the time of admission: e.g., those with established VTE, atrial fibrillation, acute myocardial infarction, ischemic stroke, those on continuous renal replacement therapy, extracorporeal membrane pulmonary oxygenation, hemodialysis, and mechanical valve implantation status.

Related Conditions & MeSH terms

• Clinical Decision Support Systems
• Digital Health
• Thromboembolism
• Venous Thromboembolism

Intervention

Other:
• Application of the modified DeVTEcare system
The modified DeVTEcare system, which incorporates bundled guideline-based VTE prevention measures, will be utilized to assist healthcare providers in VTE prophylaxis after September 2024.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing

References & Publications (3)

Durieux P, Nizard R, Ravaud P, Mounier N, Lepage E. A clinical decision support system for prevention of venous thromboembolism: effect on physician behavior. JAMA. 2000 Jun 7;283(21):2816-21. doi: 10.1001/jama.283.21.2816. — View Citation

Henke PK, Kahn SR, Pannucci CJ, Secemksy EA, Evans NS, Khorana AA, Creager MA, Pradhan AD; American Heart Association Advocacy Coordinating Committee. Call to Action to Prevent Venous Thromboembolism in Hospitalized Patients: A Policy Statement From the American Heart Association. Circulation. 2020 Jun 16;141(24):e914-e931. doi: 10.1161/CIR.0000000000000769. Epub 2020 May 7. Erratum In: Circulation. 2020 Jun 16;141(24):e932. Circulation. 2021 Feb 16;143(7):e249. — View Citation

Jin ZG, Zhang H, Tai MH, Yang Y, Yao Y, Guo YT. Natural Language Processing in a Clinical Decision Support System for the Identification of Venous Thromboembolism: Algorithm Development and Validation. J Med Internet Res. 2023 Apr 24;25:e43153. doi: 10.2196/43153. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital VTE	In-hospital VTE refers to the occurrence of a VTE in a patient who did not have a VTE on admission but developed one during the course of their hospital stay.	During the hospitalization (assessed up to 30 days)
Secondary	Guideline-compliant prescription of VTE prophylaxis	Guideline-compliant prescription of VTE prophylaxis refers to the adoption of risk stratification to guide clinicians' decisions to prescribe guideline recommended thromboprophylaxis.	During the hospitalization (assessed up to 30 days)
Secondary	Preventable VTE	Preventable VTE is defined as occurring in a high-risk patient not prescribed adequate VTE prophylaxis.	During the hospitalization (assessed up to 30 days)
Secondary	Hospital-related VTE death	Hospital-related VTE death is defined as patient who died during the present hospitalization while having an in-hospital VTE event.	During the hospitalization (assessed up to 30 days)
Secondary	Major bleeding	The major bleeding events are defined by the International Society on Thrombosis and Hemostasis (ISTH) and are further categorized into VTE prophylaxis-related major bleeding and VTE treatment-related major bleeding.	During the hospitalization (assessed up to 30 days)
Secondary	Non-major bleeding	The non-major bleeding events are defined by the International Society on Thrombosis and Hemostasis (ISTH) and are further categorized into VTE prophylaxis-related non-major bleeding and VTE treatment-related non-major bleeding.	During the hospitalization (assessed up to 30 days)